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The FDA sent a warning letter to Shire saying that promotional materials for Intuniv, an extended-release drug for attention-deficit/hyperactivity disorder, present "unsubstantiated effectiveness claims" and "omit and minimize important risk information." A Shire spokesman said the company is "reviewing information and working closely with the FDA in order to update the materials with the correct information."

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Impax Laboratories has won FDA approval to market a generic version of Intuniv, or guanfacine, a drug developed by Shire for patients ages 6 to 17 with attention-deficit/hyperactivity disorder. The treatment will be marketed in 1-, 2-, 3- and 4-mg strengths.

The FDA sent a warning letter to Shire saying that promotional materials for Intuniv, an extended-release drug for attention-deficit/hyperactivity disorder, present "unsubstantiated effectiveness claims" and "omit and minimize important risk information." A Shire spokesman said the company is "reviewing information and working closely with the FDA in order to update the materials with the correct information."

Masimo has received 510(k) clearance from the FDA for its Pronto-7, a needleless device that can quantify hemoglobin levels in less than 60 seconds, as well as pulse rate and other vital signs. The hand-held tool was already approved in Europe.

The FDA deferred its approval decision on extended-release Intuniv, Shire's drug candidate for attention-deficit/hyperactivity disorder, because of unresolved labeling discussions. Shire said the company remains confident that the treatment will be approved in the fourth quarter.

Shire said the FDA has asked for more data on Intuniv, a treatment for attention-deficit hyperactivity disorder. Shire also makes the ADHD drug Adderall, but Intuniv is a nonstimulant and not known to have a potential for abuse or dependence.